Tissue management system

ABSTRACT

The present invention provides a comprehensive tissue management system for transplantable materials like tissues and organs. The tracking portion of the system prompts and verifies that staff members of a medical establishment like a hospital have handled, stored, transported, reconstituted, and used the tissue or organ materials in a safe and regulatory-compliant manner from the point of receipt to the point of issuance or surgical use throughout the hospital&#39;s organization. The tracing portion of the system creates an integral record that documents which hospital staff members have provided which processing steps to the tissue or organ, any associated materials used in conjunction with such tissue or organ, and an identification of the tissue or organ that was transplanted or implanted inside a patient. Such a system will enable adverse reaction investigations for transplant patients, and recalls of transplantable materials.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 11/975,525 filed onOct. 19, 2007, which is a continuation-in-part of U.S. Ser. No.11/584,357 filed on Oct. 20, 2006, which is a continuation-in-part ofU.S. Ser. No. 11/540,844 filed on Sep. 29, 2006, which claims thebenefit of the U.S. provisional application No. 60/826,492 filed on Sep.21, 2006, all of which are hereby incorporated by reference in theirentirety.

FIELD OF THE INVENTION

This invention relates generally to transplantable materials includingcells, tissues and organ transplants (“TM”), and non-biologic implantmaterials, such as titanium screws and silicone breast implants (“NBI”),used within the medical field, and more specifically to a computersoftware-based system for ensuring the safe and appropriate handling ofsuch TM and NBI from receipt to their use in surgical procedures andtracing such TM and NBI later in response to an adverse reactioninvestigation or recall. The computer software-based system provides fortracking the movement of NBI from receipt into a medical establishmentfacility to their use in a surgical procedure.

BACKGROUND OF THE INVENTION

The human body is made up of trillions of cells that allow it tofunction, grow, heal and defend itself against hundreds of diseases.Cells of the same type combine to form tissues. Examples of tissuesinclude: connective tissue which helps to support and join togethervarious parts of the body; epithelial tissue which acts as a coveringfor external and internal body surfaces; muscle tissue which consists ofthreadlike fibers that can contract to make movement of the bodypossible; and nervous tissue which carries signals to permit variousparts of the body to communicate with each other.

An organ consists of multiple tissues working to perform a particularfunction. For example, connective, epithelial, muscle and nervoustissues all combine to make up the heart which pumps blood throughoutthe body. The body's skin, skeletal, muscular, digestive, respiratory,circulatory, urinary, lymphatic, endocrine and nervous systems are allformed from multiple organs that in turn are made up of severaldifferent kinds of tissues.

When tissues or organs are damaged or diseased, healthy cells, tissues,or organs from one person may be transplanted to replace the diseased,damaged, or destroyed tissue or organ in another person. Bloodtransfusion is the most common type of tissue transplanted. After bloodproducts, the most common transplant from person to person (allogeneic)is cadaveric tissue: e.g., bone, tendons, skin, cornea, heart valves andblood vessels. There are more than a million tissue transplants a year;most of these are bone and other musculoskeletal tissues, and in manycases involve some form of a NBI. For instance, bone transplants arecommonly used in spinal surgery and the transplanted bone attracts newbone formation and eventually becomes an indistinguishable part of therecipient's bone (osteoinductive). There are various devices that can beused as structural grafts: cages to hold bone grafts or bonesubstitutes, such as bone graft extenders, demineralized bone matrix(“DBM”), and autogenous bone. NBI, such as titanium or carbon-fibercages, or resorbable cages or screws, may help to anchor and support theimplanted bone, and provide osteoconduction. Cornea transplants improvethe vision of the patients whose corneas have become scarred by injuryor clouded by age or infection. Skin transplants can be used totemporarily cover areas of the body of burn victims to reduce the riskof infection, prevent the loss of fluids and decrease pain until skinfrom another part of the patients own body can be utilized for a morepermanent transplant. Bone marrow transplants replace the blood-formingtissue within a patient's bones to treat certain kinds of cancer andserious blood disorders.

Tissues are usually isolated and processed for easier use in surgicalprocedures. For example, whole bones can be used in transplant, or bonescan be cut into various shapes or powdered for use in filling voids.Bones from different areas of the body can be combined and processed byproprietary methods into new products designed for unique uses insurgical procedures.

Some tissues can be treated more harshly than others, and the processingmethods will determine the likelihood that a tissue product carries aninfectious risk. Tissues such as bone that are treated with alcohol,oxidative agent or irradiation have very low or non-existent risks, butsome surgeons are reluctant to use these for fear that the functionalityof the product has been compromised. Use of antibiotics does notguarantee that bacteria have been totally removed from the graft andhave no effect on viruses.

The heart, lungs, kidney and liver are commonly transplanted organs.Such transplant procedures can enhance the quality of life for somepatients and restore the health of people who may otherwise die. Someorgans like the heart and lungs cannot survive outside the body for morethan a couple of hours. Thus, they usually are transplanted quickly froma patient who has been declared brain dead and surviving only bymechanical means in order to perfuse the organs until they can betransplanted to the matched recipient patient in need. Organ registrieshave been established in many states and countries to identify andprioritize transplant patients in need of an organ. Their position onthe registry list will typically determine, when, if ever, they canqualify for a transplant. Many tissues like bone, corneas and skin,however, can be held for longer periods outside the human body. Suchtissues can be stored for future transplantation or implantation inrefrigerators or freezers at independent tissue banks or tissueprocessors, and subsequently distributed to storage units withinhospitals.

Infection from contaminated grafts is the greatest risk fromtransplantation. Tissue and organ transplantations have been associatedwith risk from HIV, hepatitis, bacterial infections, prion associateddiseases such as Creutzfeldt-Jakob Disease (“CJD”), rabies, fungusinfections, West Nile virus, leucocytic choriomeningitis, as well asmany others. Any transplant operation carries the risk of rejection bythe body's immune system or infection. Surgeons try to prevent rejectionby choosing a donor with the same blood type as the recipient patient.Matching HLA antigens between the donor and recipient may also beimportant for kidney and bone marrow transplants. Immuno-suppressivedrugs like azathioprine, prednisone and cyclosporine are also commonlygiven to the transplant patient to help prevent tissue or organrejection. Because such immuno-suppressive drugs act to reduce immuneactivity within the patient, they may also hinder the body's ability todefend itself against infections.

Improper handling of the cells, tissues or organs prior to their use inthe transplant operation can adversely impact their functionality onceimplanted in the patient, or greatly increase the likelihood of aninfection or other adverse reaction by the patient. For example, the TMmay be stored at the incorrect temperature or outside a sterileenvironment. The packaging surrounding the TM may become perforated.Prior to surgery, TM may be improperly reconstituted. Blood and tissuebanks are typically better than surgical units in hospitals atestablishing some procedures for storing cells, tissues; however, oncethese materials leave their facilities, the safety system candeteriorate rapidly. Hospitals rarely have established policies andprocedures for receiving, handling, storing and reconstituting tissuesbefore their use in surgery. Instead, they allow a great deal ofindividual discretion to the hospital physicians and nurses for thesecritical activities. Consequently, standards and procedures can differgreatly across the hospital staff to the potential detriment of thepatient.

Many hospitals perform no qualification of the donor sources of tissuethat they use in surgical procedures. To the extent that the hospitalsinstitute any certification process for their tissue suppliers, theprocess tends to be directed to issues of price and delivery schedule,instead of whether the supplier is properly registered, licensed, andcompliant with prevailing industry safety standards. It is as if tissueis just another form of paper clips that need to be stocked in thehospital's inventory. Suppliers of tissue have even been known onoccasion to bring these critical tissues in their car trunks to thehospital operating room without monitoring storage conditions.

While hospital surgical departments may possess refrigeration units forstoring tissue, their staffs frequently do not know how to monitor andcontrol the equipment. Moreover, few surgical units possess thenecessary training to reconstitute tissue. The blood bank and surgicalunits within the hospital may possess individual staff members withknowledge but they are outside of each other's control.

All of these problems can lead to adverse reactions, including seriousinfections, illnesses and even death for the transplant patient. Forexample, a healthy, 23-year-old Minnesota student underwent a routine,elective knee surgery in 2004 in which cartilage sourced from a cadavervia a reputable tissue bank was used by the surgeon to repair the knee.Unbeknownst to the surgeon, the corpse sat unrefrigerated for 19 hours,and had been rejected by two other tissue banks. The cartilage also hadnot been adequately treated to kill bacteria. The student died four daysafter the surgery from a raging infection.

In another reported case, a California man died in 2006 from the effectsof a fungus-infested heart valve that had been recently implanted.Indeed, the United States Food and Drug Administration reports that 207deaths occur each year from fungus-contaminated heart valves alone.

When such an incident occurs, good medical practice and public healthpolicy requires an immediate investigation of the patient's condition todetermine whether the infection, illness or death was caused by thetissue, organ, NBI, or surgical procedure, as opposed to an independentcondition in the patient. If the surgical procedure was faulty, then thetransplant procedure needs to be traced back to the surgeons and nursesinvolved, the operating room environment, and the equipment involved toreduce the likelihood of a repeat event. If it was traced back to a NBImalfunction or manufacturing defect, then it needs to be traced back tothe supplier. If the TM was the cause, then it needs to be traced backto the donor or supplier so that other TM from the same source isimmediately removed from inventory and other patients who are transplantrecipients of similar TM from the same supplier or donor can be warnedand provided appropriate medical care and counseling. Yet, such atracing process is frequently impossible because many hospitals fail tolog in the TM and NBI that they receive from suppliers and track theiruse in surgical procedures. Quality problems in hospitals culminated in2005 when there was a major recall of tissue products inappropriatelyreleased by several tissue banks. Yet, repeated attempts to locatetissue products at hospitals that had not been transplanted failedmiserably, thereby resulting in other patients receiving potentiallycontaminated tissue products. During the same recall, hospital protocolsfor tracing recipients of the potentially contaminated products werefound to be substantially inadequate or entirely absent. Close to oneyear later, there are recipients yet to be identified who have notreceived appropriate diagnostic treatments and modalities.

In one incident reported within the industry, organs provided by a donorinstitution resulted in several cases of hepatitis C in the transplantedpatients. Because the hospital failed to notify the tissue bank for 16months, other infected patients were deprived of treatment while thisdisease could be treated, resulting in additional deaths. A $32 milliondamage award resulted from a subsequently filed litigation.

In addition, there have been reported cases of physicians takingdiseased tissue from in-hospital patients and transplanting it intounsuspecting, healthy patients. These tissues have not been able to betracked back to the original source, resulting in the recipient's death.

The transplant industry relies upon “tissue usage information cards”that a hospital is supposed to return to the issuing tissue bank after asurgical procedure is completed. Such cards allow the tissue bank tomonitor usage of their tissue and notify everyone who has receivedsimilar tissue for recall purposes. However, hospitals only return50-85% of these cards to the tissue banks.

In the case of adverse reaction investigations, hospitals do not usuallydefine what constitutes an adverse reaction and therefore what should bereported. Instead, the reporting responsibility is left to thephysician's discretion. Physicians often resort to a gram stain test orcultures on the tissue prior to surgery. But, such test results can bemisleading and grossly inadequate to detect diseased tissues.

There are associated risks with tissue transplantation. There arenumerous reports of transplant-transmitted infections, including somethat resulted in death. For example, there was a recent article(Morbidity and Mortality Weekly Report 2002 (“MMWR”); 51 (March15^(th)): 207-210) that reported that on Nov. 7, 2001, a 23-year-oldmale from St. Cloud, Minnesota had knee surgery using a refrigerated“fresh” femoral condyle. On Nov. 10, 2001, the patient developed kneepain and severe hypotension. On Nov. 11, 2001, the patient died fromclostridium sordelli sepsis that came from the tissue transplant. OnNov. 13, 2002, a 17-year-old male in Illinois also received a “fresh”femoral condyle and meniscus from the same donor. On Nov. 14, 2002, thepatient developed a fever and septic arthritis. The presumed cause was aclostridia infection. Likewise, usage of antibiotics in patients priorto surgery can mask problems contained in tissues.

Because of these abuses and other safety problems within hospital andtissue bank environments, regulatory and standard setting agents likethe Joint Commission for the Accreditation of Health Care Organization(“JCAHO”), American Association of Blood Banking (“AABB”), Food & DrugAdministration (“FDA”), and the College of American Pathologists (“CAP”)are currently implementing mandates for the safe handling, storage, use,and tracing of TM. However, these mandates provide no instructions orguidelines to the hospital or tissue bank for how to comply. Therefore,such hospitals and tissue banks are left with regulatory and legalliability for their failure to comply, but no tools to use to comply.

Some instances of tissue tracking are reported in the prior art. Thus,U.S. Published Application No. 2005/0262088 filed by Solis et al.discloses a system for organ procurement and transfer. While this systemmaintains the security of patient information, it does not address thesafety of the organ or organ match for the patient.

U.S. Published Application Nos. 2005/0010437 and 2005/0010449 filed byAbukwedar teaches an organ donation system that permits a person todonate or agree to donate one type of organ in order to be accordedpreferential receipt of another organ. This exchange program, however,does nothing for tracking the safe receipt, handling, or use of theorgan, or tracing its use after surgery.

U.S. Published Application No. 2005/0285715 filed by Comunale disclosesa container with an electronic lock controlled by a computer system forcarrying blood samples or organs to a hospital in a secure manner. Whilethis transportation container can prevent theft or contamination of theorgan by strangers, it does nothing to prevent unsafe handling, storage,or treatment by the hospital of the organ.

Other prior art systems exist within a diagnostic laboratory, fortracking biological samples. Thus, U.S. Published Application No.2003/0120633 filed by Torre-Bueno assigns unique bar codes to samplesthat can be scanned and read during processing of the sample within thelab. U.S. Pat. No. 5,416,029 issued to Miller et al. employs color-codedembedding media and corresponding color-coded slides accompanied bywords, numbers, or symbols to identify the biological samples. U.S. Pat.No. 5,842,179 issued to Beavers et al. discloses a cryogenic freezerwith a security key pad for receiving and tracking information toidentify the location of blood and tissue samples stored within thefreezer, and when a capsule has been removed from the freezer. Whilethese types of systems may be useful for keeping track of thousands ofbiological samples stored within a diagnostic laboratory, they donothing to ensure the safe handling, storage, and treatment of thesample within the lab.

Other prior art references disclose systems for keeping track of thewhereabouts of surgical supplies used during surgery to detect if theyhave been accidentally left inside the patient after surgery. See, e.g.,U.S. Published Application No. 2002/0049650 filed by Reff, and U.S. Pat.No. 6,861,954 issued to Levin. U.S. Published Application No.2002/0082957 filed by Krassi specifies an inventory control system forchemical reagents used within a clinical or diagnostic lab. Suchinventory control tracking systems can detect the location or number ofproducts, but once again, they do not address the proper handling andstorage of those products.

A comprehensive system for tracking the appropriate handling, storageand use of tissues throughout the tissue bank's or hospital's chain ofcustody of the materials would be beneficial. Also advantageous would bea system that reliably enables the tracing back of tissues from patientto supplier after an adverse reaction is detected. For tissue and bloodbanks and larger healthcare providers, this system would ideally becomputerized due to the comparatively large number of TM that need to beprocessed and handled.

Indeed, computer systems are used within the healthcare industry tostore, monitor, and track patient information. The hard drives of suchcomputer systems can store large volumes of data which can bepassword-protected. National home health agencies, hospitals and medicalclinics can afford to employ large computer systems run on “point ofcare” software that permit the clinician to call upon a file containingthe medical chart for a patient from the computer's hard drive, reviewthe patient's initial physical assessment, clinical procedures andmedicines administered in the past, and update the file for any newclinical procedures or medicines prescribed. Such computer softwaresystems provided by companies like 3M Corporation, Care Package, and St.Louis Software are readily accessible by different doctors or nurses atthe hospital or clinic. However, such point-of-care software systems arenecessarily complex because of the large number of patients and clinicalstaff required to access the information It is not uncommon for suchprograms to require expensive database platform servers and cost upwardsof $100,000.

Other computer software systems are known within the industry forassisting the administration of medical care. For instance, U.S.Application 2004/0186746 filed by Angst on Sep. 23, 2004 discloses a USBflash memory device that permits a user to carry his personal medicalrecords with him and launch it on the hard drive of any computer. Theinformation contained within the flash memory device can be protectedvia a password or encryption. In this manner, the user has accuratemedical records for himself when he visits the doctor, or in case of amedical emergency.

Computerized information devices can also be used to monitor a patientin the field. U.S. Application 2004/0117207 published by Brown on Jun.17, 2004 teaches a handheld microprocessor device used by a patient tomonitor and store, e.g., blood glucose level data. This information canthen be transmitted to a doctor at a remote location and downloaded bythe doctor onto a computer for storage or to produce medical reports.

Many patients do not actually visit a hospital, medical clinic, ordoctor's office for medical care due, e.g., to a loss of mobility orfrequency of required care. Thus, the doctor or nurse may visit thepatient at her home. In such cases, the medical practitioner is awayfrom his office where the medical records, medical treatises andstudies, etc. reside. Therefore, U.S. Patent Application 2004/0249666published by Napolitano et al. provides a healthcare computerized systemthat provides medical practitioners with best practice patient diseasediagnosis and treatment information. In essence, it enables the medicalpractitioner to carry a bookcase of medical treatises and publishedstudies with her. The practitioner can use this portable information todiagnose and treat the patient in the field.

U.S. Patent Application 2005/0027567 published by Taha on Feb. 3, 2005on the other hand discloses a data management system containing a fieldmodule used by the medical practitioner to collect data for the patientand communicate it back to a server at the home office for use by adoctor or nurse to tell the field practitioner what steps to take totreat the patient. The patient can also use this field module tocommunicate with his caregiver back at the medical office. See also U.S.Application 2002/0194029 published by Guan et al. on Dec. 19, 2002,which discloses a medical information management system that permits amedical practitioner to carry a patient's medical records with him inimage form in the field, consult medical on-line databases, andcommunicate remotely with other members of the medical staff.

Computer systems are also widely used for dispensing medicines inhospitals via, e.g., an infusion pump. See U.S. Application 2005/0065817published by Mihai et al. on Mar. 24, 2005; 2005/0055244 published byMullan et al. on Mar. 10, 2005; and 2005/0055242 published by Bello etal. on Mar. 10, 2005. Such systems typically track and monitor thepatient's symptoms to indicate how the administered drug is affectingthe patient.

These information management systems available within the healthcareindustry typically focus upon “point of care” for the patient, keepingtrack of all the clinical data for treatment of that patient. At leastone computer system is also available from Owens & Minor within thehealthcare industry for tracking TM. However, this system providesessentially the same functionality as conventional paper recordssystems. It does not permit queries directed to TM data, does not trackthe healthcare institution's processing and handling of the TM, andprovides no mechanism for prompting or enabling the healthcareinstitution to investigate an adverse reaction occurring in the patient.Likewise, large national blood banks use computerized systems to tracktheir massive inventories of blood samples. Such systems keep track ofthe blood type of each sample, so that a blood sample is not supplied toa patient with an incompatible blood type. Such systems will alsoprovide advice regarding which blood types are compatible and which onesare not from a safety stand point. However, these blood bankcomputerized systems represent little more than inventory systemswithout any functionality for tracking the processing and handling ofthe blood samples.

Thus, a comprehensive computerized system that permits the tracking ofthe appropriate handling, processing, storage, and use of tissuesthroughout the tissue bank's or hospital's chain of custody of thematerials would be beneficial, particularly if its built-infunctionality prompts staff members of the tissue bank or hospital torecord necessary data and properly handle, process, store, and use thetissue or organ product. Such a computerized system would also beadvantageous if it provides a search or query functionality thatreliably enables the tracing back of tissues from patient to supplierafter an adverse reaction is detected, or the tracing forward of the TMor NBI material from supplier to patient or hospital in the event of aproduct recall that is issued by the supplier or the Food and DrugAdministration.

SUMMARY OF THE INVENTION

The present invention provides a comprehensive tissue management systemfor transplant materials like tissues, organs, and non-biologicimplants. The tracking portion of the system verifies that staff membersof a medical establishment like a hospital have handled, stored,transported, reconstituted, and used the tissue, non-biologic implant,or organ materials in a safe and regulatory-compliant manner from thepoint of receipt to the point of issuance or surgical use throughout thehospital's organization. Such a system is preferably computer-based, andit should preferably be structured to provide appropriate prompts to thestaff members to take the necessary actions to handle, store, transport,reconstitute and use the tissue or organ materials in a safe orappropriate manner. Even more preferably, such system will not permitsuch staff members to carry out a critical step for handling, storing,transporting, reconstituting or using such tissue, non-biologic implant,or organ material unless data has already been entered into the systemto verify that a prior critical step has been taken.

The tracking portion of the system creates an integral record thatdocuments which hospital staff members have provided which processingsteps to the tissue, any associated materials used in conjunction withsuch tissue, and an identification of the tissue that was transplantedor implanted inside a patient, so that the tissue can be reliably tracedback to its donor or tissue bank source in the event of an adversereaction by the patient after the surgery, or the tissue or organ can betraced in response to a warning received from the donor or tissue bank.Such adverse reaction investigation is preferably conducted utilizingmedical cladistics to identify risk clades. Again, such system,preferably computer-based, should be structured to provide prompts tothe medical establishment's staff members to record and enter the dataat the same time that the processing activity is carried out in order tocreate accurate, comprehensive and contemporaneous record-keeping. Suchsystem preferably will refuse to permit the staff members to enter datainto the system for a critical processing step unless data from aprevious critical processing step has already been entered.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings:

FIG. 1 is a schematic illustration of a process flow for the transferand use of transplantable material within a clinical environment.

FIG. 2 is a flow diagram illustrating an example embodiment of a systemfor managing a comprehensive tissue management method and recordinginformation related thereto.

FIG. 3 is a schematic diagram showing the storage and acquisitionportion of a comprehensive tissue management system.

FIG. 4 is an interactive graphic user interface illustrating a main(home) menu of functions for the comprehensive tissue management system.

FIG. 5 is an interactive graphic user interface illustrating a certifiedsuppliers list screen.

FIG. 6 is an interactive graphic user interface illustrating a supplierinformation subscreen.

FIGS. 7-9 are interactive graphic user interfaces illustrating tissueorder screens.

FIG. 10 is an interactive graphic user interface illustrating a catalogpage accessible within the comprehensive tissue management system fordefining available supplier products.

FIGS. 11-12 are interactive graphic user interfaces illustratingadditional tissue order screens.

FIGS. 13-16 are interactive graphic user interfaces illustrating tissuereceiving screens.

FIG. 16 a is an interactive graphic user interface illustrating a recordstorage temperature screen.

FIG. 17 is a schematic diagram showing the release and utilizationportion of a comprehensive tissue management system.

FIG. 17 a is an interactive graphic user interface illustrating a tissuestorage unit screen.

FIGS. 18-20 are interactive graphic user interfaces illustrating tissuetransfer screens.

FIG. 21 is an interactive graphic user interface illustrating a tissueinventory screen.

FIGS. 22-28 are interactive graphic user interfaces illustrating tissueimplant screens.

FIGS. 29-34 are interactive graphic user interfaces illustrating tissueadverse reaction investigation screens.

FIGS. 35-39 are interactive graphic user interfaces illustratingsupplier tissue recall screens.

FIG. 40 is an interactive graphic user interface illustrating a reportsgeneration screen.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A comprehensive system for safe management of transplantable material isprovided by the invention. In its preferred embodiment, the system iscomputer-based. Such invention enables the proper qualification ofsuppliers; logging and inspection of incoming transplantable material;product maintenance; integrated tracking and verification of thehandling, storage, and use of transplantable materials in a safe andregulatory-compliant manner from the point of receipt to the point ofissuance/final disposition throughout the medical establishment. Thesystem also provides for prompt investigation of any adverse reactionsuffered by a patient who receives the transplantable material through asurgical procedure. Additionally, it ensures a complete documentedhistory of the transplantable material within the medical establishmentso that the transplantable material can be traced back to its supplierin the event that a product recall of transplantable material iswarranted either by a supplier or a regulatory agency. This allows atimely identification, notification and treatment of other patientsreceiving similar transplants.

The system of this invention is tailored to the specific medicalestablishment and its handling and use of transplant materials, so as toenhance the integrity of the system. Moreover, the system prompts staffmembers of the medical establishment to carry out the necessary stepsfor the safe and appropriate processing of the transplantable materialand to record the associated data at the time that the activity isconducted. More preferably, the system will not allow data entry for acritical processing step unless the data from a prior criticalprocessing step has already been entered. In this manner, the systemprovides a self-auditing function to enhance the integrity of itstracking and tracing functionalities.

For purposes of the present invention, “transplantable material (“TM”)”means human cells, tissue, or organs intended for implantation,transplantation, infusion, or transfer to a patient, including, but notlimited to: musculoskeletal tissues like bone, tendons, fascia,ligaments, cartilage, and bioengineered bone products; skin;cardiovascular tissues like heart valves, arteries, veins, andpericardium; reproductive cells like sperm, semen, oocytes, fertilizedeggs, and embryos; cellular therapies like stem cells, progenitor cells,cord blood, placental blood, chondrocytes, bone marrow, and neuralcells; dura mater; breast milk; eyes; corneas; organs; islet cells;parathyroids; autologous tissue; and synthetic and xenographic tissueused as replacements for human tissue. For purposes of this application,transplantable materials also include non-biologic implants (“NBI”),including but not limited to: titanium screws, titanium or carbon-fibercages or resorbable cages, fixation systems, saline or silicone breastimplants, synthetic polymers, prosthetic hips, knees and other jointcombinations thereof. Transplantable material also includes surgicalinstruments, equipment, reagents, supplies, and other materialsassociated with the transplanting or implanting of any transplantmaterial into a patient.

In the context of the present invention, “medical establishment” meansany organization directed to the storage, research, transplantation, orimplantation of transplantable materials, including but not limited tohospitals, medical clinics, surgical centers, fertility clinics, bloodbanks, tissue banks, organ donor banks, university and researchfacilities, diagnostic laboratories, and willed body programs.

As used within this application, “supplier” means any person or entitythat provides a transplantable material to a medical establishment on aprofit or non-profit basis, including but not limited to live ordeceased organ donors, tissue banks, blood banks, fertility clinics,laboratories, and manufacturers of synthetic or bioengineered tissue,NBI, or organ products.

For purposes of the present invention, “patient” means any recipient bytransplantation or implantation of a transplantable material, includingwithout limitation humans, domesticated animals like dogs, cats, andhorses, and working animals like bulls and horses.

As used within this application, “adverse reaction” means anyundesirable effect or untoward outcome consequent to or reasonablyrelated to the transplantation or implantation of transplantablematerial into a patient, including but not limited to diseasetransmission, other infectious complications like fever or woundinfection attributed to the graft or positive culture of the graft atthe time of use, immune rejection, and unexplained synovitis followingtendon implant.

A freeze-dried bone graft implanted into a human patient will be used asan exemplary transplantable material for purposes of describing thecomprehensive tissue management system of the present invention in thisapplication. It is important to appreciate, however, that any other typeof transplantable material (tissues, cells, NBI, or organs) or patientis covered by this application, as well.

FIG. 1 shows the history of a transplantable material from purchaseorder to entrance into the hospital to the final implantation in apatient, and investigation of adverse reactions. When a surgeon is inneed of a bone graft 12, the hospital 16 will acquire it from a tissuebank 14 by placing a purchase order 11. The bone graft 12 will beacquired by hospital 16 in accordance with the terms of its supplyagreement with the tissue bank 14. Once the bone graft 12 is deliveredto hospital 16 by tissue bank 14, it will typically be stored by thehospital. The location of storage 18 varies by hospital. It can includethe blood bank, surgical department, central supply, etc. until the bonegraft is needed by the hospital's surgical department 20 forimplantation into patient 22. The comprehensive tissue managementtracking portion 26 of the present system prompts the hospital staff toundertake all of the activities necessary for the safe handling,storage, reconstitution, and implantation of the bone graft 12 inaccordance with regulatory requirements and industry standards from thepoint of receipt by the hospital 16 until the bone graft is implantedinto patient 22, and collects the necessary information to document thestaff's compliance therewith.

Once the bone graft 12 has been implanted into the patient 22, themedical establishment's responsibility to the patient is not complete.Instead, the surgeon or other staff member of the hospital 16 needs toperform a post-operative assessment 28 of the patient's condition todetermine whether any adverse effect like infection caused by the bonegraft or surgical procedure has occurred. The hospital then notifies thetissue bank by usage of the tissue utilization information card (“TUIC”)to whom the tissue was implanted. If an adverse reaction occurs, then aninvestigation 30 needs to be promptly commenced to determine whether theadverse reaction was caused by the bone graft, the surgical procedure,the reagents used to reconstitute the bone graft, or some independentcondition of the patient 22. The comprehensive tissue management tracingportion 32 of the present system enables the reliable tracing of thebone graft back to the tissue bank 14 in the event of an adversereaction investigation 30, or the tracing forward of the bone graft 12to the patient 22 or the storage inventory location 18 in the event thattissue bank 14 or a regulatory agency like the FDA issues a recall orother warning.

The comprehensive tissue management system tracing 26 and tracking 32portions of the present invention must have compiled a sufficientdocumentary history of the bone graft throughout its life in thehospital to enable the investigation to identify each aspect of thehandling, storage, reconstitution, and surgical implantation of the bonegraft 12 back to tissue bank 14 as the supplier in the event that arecall of other transplantable material from the same donor isnecessary. Determination of medical treatment of other patientsreceiving such similar tissue products must be conducted.

Referring to the example embodiment of FIG. 2, the comprehensive tissuemanagement system 10 comprises a general programmable computer 42 havinga central processing unit (“CPU”) 44 controlling a memory unit 46, astorage unit 48, an input/output (“I/O”) control unit 50, and at leastone monitor 52. Computer 42 operatively connects to database 40,containing, e.g., tissue data, patient data, and clinical services data.It may also include clock circuitry, a data interface, a networkcontroller, and an internal bus. One skilled in the art will recognizethat other peripheral components such as printers, drives, keyboards,mice, barcode scanners, and the like can also be used in conjunctionwith the programmable computer 42. Additionally, one skilled in the artwill recognize that the programmable computer 42 can utilize knownhardware, software, and the like configurations of varying computercomponents to optimize the storage and manipulation of the data andother information contained within the comprehensive tissue managementsystem 10. This computer system can be located on premise at a facility,or in a hosted environment through, e.g., the Internet.

Referring to FIG. 2, comprehensive tissue management system 10 includesa software program 54 having a plurality of graphic user interfaces(“GUIs”) that permit the input of data concerning the patient 22, thepurchase order 11 placed for the bone graft 12, and the receipt,storage, handling, transport, reconstitution, and surgical use of thebone graft with respect to patient 22. Data may also be inputted withrespect to the post-operative assessment 28 of the transplant orimplant, and any adverse reaction investigation 30 resulting therefrom.Outputs produced by such software program 54 include search resultsdirected to the bone graft 12, its current location in storage location18 or the patient 22 into which it was transplanted or implanted, andall processing steps carried out with respect to the bone graft andwhich staff members conducted those processing steps. The softwareprogram 54 can also produce and print a series of reports documentingthis information.

The GUI can also be used to display the status of the transplantablematerial to any or selected staff members participating in monitoringthe transplantable material. Additionally, the comprehensive tissuemanagement system, computer system, and GUI can be connected to externaldevices such as refrigeration units to send a current temperaturereading or to notify those monitoring the tissue that the temperature ofthe refrigeration unit has decreased or increased beyond a predeterminedrange. The comprehensive tissue management system, computer system, andGUI can be connected to any type of device that needs to be monitored.

Data may also be inputted with respect to the post-operative assessment28 of the transplant or implant, and any adverse reaction investigation30 resulting therefrom. Outputs produced by such software program 54include search results directed to the bone graft 12, its currentlocation in storage location 18 or the patient 22 into which it wastransplanted or implanted, and all processing steps carried out withrespect to the bone graft and which staff members conducted thoseprocessing steps. The software program 54 can also produce and print aseries of reports documenting this information.

The software program 54 may be designed to be an expression of anorganized set of instructions in a coded language. These instructionsare programmed to facilitate the monitoring of the transplantablematerial from at least the point of sourcing, handling, transportation,storage, reconstitution and/or surgical implantation. The instructionsmay include the entry, reporting and/or reading of data relating totime, date, location, temperature, condition of the tissue, and/or anyother information needed for monitoring the transplantable material.

The computer system on which the system resides may be a standard PC,laptop, server, handheld wireless device, or any automated dataprocessing equipment capable of running software for monitoring theprogress of the transplantable material. The CPU controls the computersystem and is capable of running the system stored in memory. The memorymay include, for example, internal memory such RAM and/or ROM, externalmemory such as CD-ROMs, DVDs, flash drives, or any currently existing orfuture data storage means. The clock circuit may include any type ofcircuitry capable of generating information indicating the present timeand/or date. The clock circuitry may also be capable of being programmedto count down a predetermined or set amount of time. This may beparticularly important if a particular type of tissue needs to berefrigerated or implanted in a predetermined amount of time.

The data interface allows for communication between one or more networkswhich may be a LAN (local area network), WAN (wide area network), or anytype of network that links each party handling the tissue. Differentcomputer systems such as, for example, a laptop and a wireless devicetypically use different protocols (i.e., different ways to coordinatecommunication). To allow the disparate devices to communicate, the datainterface may include or interact with a data conversion program ordevice to exchange the data. The data interface may also allow disparatedevices to communicate through a Public Switched Telephone Network(PSTN), the Internet, and private or semi-private networks.

The acquisition and storage portion 26 of the comprehensive tissuemanagement system 10 is shown in detail in FIG. 3. The first aspect ofthe system is supplier certification 62 of the tissue bank 14. Thepresent invention prompts the medical establishment to create criteriato determine the guidelines for selecting a supplier.

Rather than merely rely upon the name and reputation for quality andsafety of the supplier as many hospitals do, this process step of thesystem requires affirmative verification that the tissue bank complieswith all of the regulatory requirements and industry standardsapplicable to the sourcing, storage, and handling of transplantmaterials. At the most basic level, this can consist of documenting thatthe tissue bank 14 is currently registered with the FDA to supply thatkind of tissue—in this case bone graft 12. Such FDA registrationdocumentation may be obtained directly from the tissue bank 14, or fromthe FDA, including the FDA's Website:https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/index.cfm.

Some states like New York, California, Georgia, Maryland, and Floridarequire that tissue source facilities (processors, tissue banks, anddistributors) be specially licensed for this purpose. Again,documentation of this state license may be obtained directly from tissuebank 14, or else from the applicable state licensing agency. One mustensure that the FDA registration and applicable state licensure pertainto each type of transplant material to be sourced from tissue bank 14.Supplier certification step 62 more preferably may include directlyauditing the tissue bank concerning their policies and procedures forsourcing, storing, handling, and transporting the transplantablematerials, and personally inspecting their facilities. Much relevantinformation can be obtained from such direct efforts to certify theperformance of the tissue bank 14.

This supplier certification step 62 can also preferably be supported bythe hospital 16 entering into a memorandum of understanding or othercontract with the tissue bank to comply with all regulatory requirementsand industry standards for safely sourcing, storing, handling andtransporting the transplantable materials. The tissue bank may take itsresponsibilities more seriously if it risks contractual breach anddamages in addition to potential loss of its FDA registration and statelicense.

The home screen 60 of the software program 54 is shown in FIG. 4. Bymarking or clicking a button or similar marking indicator, a user canactivate myriad functionalities of the software program, such asentering certification information for suppliers 62, calling up a listof facilities 64 in the medical establishment, obtaining a list of staffmembers 66 of the medical establishment, securing an inventory listingof transplantable materials located within the facility or medicalestablishment 68, obtaining a listing of available storage locations 70for transplantable materials at the facility or medical establishment,creating documentary records pertaining to adverse reactions 72 fortransplantable materials implanted into a patient, conducting orfacilitating a recall 74 of transplantable material, and generating avariety of reports 76 related to such activities. Hyperlinks 64 a, 66 a,68 a, and 70 a provide another convenient means for selecting thesefunctionalities related to facilities and staff, suppliers oftransplantable materials, existing inventories of transplantablematerials, and storage locations for such transplantable materials.

Icon 78 on the home GUI screen 60 also enables the user to access andrecord data pertaining to a number of standard operating proceduresconducted by the medical establishment. These standard operatingprocedures can include ordering transplantable materials 80 like tissuebone graft 12 from a supplier such as tissue bank 14, receiving orderedtransplantable materials 82, moving transplantable materials betweenstorage locations 84 at the medical establishment, implanting one ormore transplantable materials in a patient 86, recording adversereactions by such patient to the transplantable materials 88 (72), andprocessing supplier recalls of transplantable materials 90 (74). Icon 92enables a search to be performed upon any of this data.

By clicking on icon 62 of the home screen GUI 60, the user calls up thecertified suppliers GUI 92 shown in FIG. 5. This list contains all ofthe certified tissue suppliers 94 that have been entered into thesoftware program. By clicking on a radio button 96 for one of thesupplier entries 94, or double clicking a name, the supplier informationGUI 98 for a specific supplier is called up, as shown in FIG. 6. This isthe principal GUI screen contained within the comprehensive tissuemanagement system 10 for providing background information concerning thesupplier.

As shown in FIG. 6, field 100 permits the name of the supplier, such asAllosource (“tissue source”) to be recorded. A specific address, contactname, phone number, and fax number for the supplier may also be entered.The field 102 contains identifying types of the supplier, such as“tissue bank” or “distributor.” The tissue classification 104 (e.g.,autologous) and tissue type 106 (e.g., other autologous tissues) may beconveniently selected from drop down boxes provided within the GUI.

The user is then prompted via “add tissue” button 108 to create entries110 for each transplantable material type that the supplier supplies.This information includes the class 112 and tissue type 114, as well aswhether the supplier is specifically approved by the medicalestablishment or regulatory authorities as a supplier of that tissuetype. Very importantly for purposes of the comprehensive tissuemanagement system 10 of the present invention, the user is prompted andrequired to enter within field 118 the FDA Registration Number for thesupplier, as well as the expiration date 120 for that FDA registration.This information represents proof that the specific supplier is in goodstanding by the FDA to supply transplantable materials. More preferably,the comprehensive tissue management system 10 could require this FDAregistration information to be entered and confirmed for a particulartype of transplantable material, since a supplier will usually not becertified by the FDA to supply all types of transplantable materials.

The Supplier Information GUI 98 shown in FIG. 6 can also prompt the userto select the appropriate “yes/no” choices for AATBI accreditation, EBAAaccreditation, state licensure, and other accreditation as required bythe hospital 16 for the supplier. In the case of a “yes” answer, thespecific number is entered for the AATB accreditation, EBAAaccreditation, state license, or accreditation.

For purposes of quality control, the supplier information GUI 98 shownin FIG. 6 can also prompt the user to identify the frequency with whichthe registration and accreditation credentials of the supplier should bereconfirmed, as well as the type of documentation that should bechecked. This information is important, since a supplier may lose itsFDA registration or state license status to supply a type oftransplantable material, and the medical establishment will want to knowthis fact before it orders transplantable materials of that type fromthat supplier. The frequency of this registration or accreditationreconfirmation will be a time period that corresponds to the riskprofile that is acceptable to the medical establishment, such as sixmonths, one year, or two years. The supplier information GUI 98 can alsoprompt the user to confirm whether or not documentation used toreconfirm the registration/accreditation credentials for the supplierhave been received and reviewed.

Finally, a medical establishment may choose to audit the supplier on aperiodic basis in order to provide additional information for confirmingthat the supplier is a safe source for providing transplantablematerials of a particular type. The medical establishment's internalrequirement that the supplier facility be audited should be noted. Oncean audit is actually performed upon the supplier facility, theperformance date, individual performing the audit, and pending documentsshould be recorded. The existence of any conformance issues resultingfrom the audit is noted, and further defined within an information box.The individual who performed the review of the audit documentation anddefined the conformance issues should be entered, along with the reviewdate. Once all of this information is entered into GUI 98, a “submit”button should be selected in order to enable the comprehensive tissuemanagement system 10 to process the information and populate screenswithin other associated GUI's of the system.

Icon 122 allows the user to delete a particular tissue entry for thesupplier. Icon 124 enables the user to edit the particular line entryfor the specific supplier.

Transplantable materials like the tissue bone graft 12 may be ordered instep 11 of the acquisition and storage portion 26 shown in FIG. 3 of thecomprehensive tissue management system 10 of the present invention. Byclicking on the “order tissue from a supplier” icon 80 of the home GUI60 depicted in FIG. 4, tissue order GUI 130 shown in FIG. 7 will becalled up to enable placement of a purchase order with a supplier forthe bone graft.

As further depicted in FIG. 7 for tissue order GUI 130, a listing ofopen purchase orders 132 placed by the medical establishment orindividual facility is provided. This data includes the title 134,status 135, number of items 136, order type 137, order date 138, andtotal fee 139 for each purchase order. Hyperlink 140 allows the user tocreate a new purchase order for transplantable material, calling up GUI142 shown in FIG. 8.

GUI 142 initiates the process for placing a purchase order. Drop downbox 144 provides the user a convenient list of supplier suppliersauthorized by the medical establishment from which to choose. Field 145lists the facility of the medical establishment, and may include a dropdown box if the medical establishment contains multiple facilities. Theorder type is identified in field 146, which may include, e.g., standardorders or open purchase orders. The purchase order number will typicallybe assigned by the medical establishment, and should be entered in field147. Identification of a courier for shipment of the orderedtransplantable material should be entered into field 148, which may alsoinclude a tracking number 149 assigned by the delivery courier service.Special notes pertaining to the order may be recorded in field 150.Finally, a confirmation number assigned by the supplier should beinserted into field 151. Clicking on “next” icon 152 calls forth GUI 154shown in FIG. 9.

GUI 154 continues the purchase order process, enabling specificidentifying information for the order to be entered. Field 156 allows aproduct catalog for a particular supplier to be selected. This preloadedcatalog is shown more fully in GUI 158 of FIG. 10, and identifies all ofthe transplantable material products available from that supplier.Selection of a particular type of transplantable material (e.g.,cortical strut) 160 shows in the lower portion of the GUI a series ofdifferent sizes of the product (frozen vs. non-frozen) 161 withcorresponding prices 162. Also of great importance, a product code 163for that specific product is included. Clicking on this product code 163automatically populates field 164 of GUI 154 shown in FIG. 9. Clickingon “look up” icon 165 prompts the software system 54 to verify thisproduct number for accuracy. Alternatively, “select” radio button 166may be chosen, which will provide a drop down box for purposes ofchoosing the transplantable material product for the purchase order fromthe pre-loaded supplier catalog.

The size of the product may be inserted into field 168, or thisinformation may be automatically provided by selection of the entry 161in GUI 158. The desired quantity of the product should be entered intofield 169, along with the price for each unit 170. Finally, the type ofinventory (e.g., stock, special order for a particular patient,consignment by the supplier, or a facility transfer) may be entered intofield 171. Clicking on “add tissue” button 172 allows additionaltransplantable material products to be added to the purchase order.

Clicking the “next” icon 174 calls forth GUI 176 of FIG. 11. This GUIenables the user to review a summary of the items 178 in the purchaseorder. Icon 179 allows a particular entry to be deleted from thepurchase order. Icon 180 takes the user back to the order GUI 154 ofFIG. 9.

Clicking the “next” icon 181 of GUI 176 will provide a purchase orderconfirmation GUI 184 shown in FIG. 12. This GUI supplies a totalpurchase price 185 for the total items ordered. Selection of the“submit” icon 186 completes the purchase order process for thetransplantable materials.

If the tissue product is being ordered for a particular patient at thehospital, as opposed to generally restocking the hospital's inventoryfor such tissue product, then this fact must be recorded so that whenthe tissue product is received by the hospital it is reserved for thatpatient. This important identifying information will include thepatient's name, date of birth, gender, and ID/Medical Record Number(“MRN”), as well as the scheduled date for the patient's surgery.

The order status will be noted in field 135 of GUI 130 shown in FIG. 7.This system will also automatically check the supplier informationsupplied under GUI 84 to make sure that that supplier possesses thenecessary current FDA registration, state license, and otheraccreditation credentials to supply the tissue product. If the supplierfor the tissue purchase order does not possess these necessarycredentials, or this information has not been entered into the system,then the user will be notified. A message will be sent by thecomprehensive tissue management system to a predetermined officialwithin the hospital who must authorize the purchase of the tissueproduct from the unapproved supplier before the purchase transaction canbe placed. Such special authorization might be justified in case of anemergency where a surgical patient is in the operating room waiting forthe tissue product. Such a purchase from an unauthorized supplier shouldbe abnormal. In this manner, the system helps to ensure as a generalmatter that the hospital purchases transplantable materials only fromproperly credentialed supplier institutions.

Next, all bone grafts 12 supplied by tissue bank 14 to hospital 16 inaccordance with FIG. 3 should be logged in accordance with step 200.Part of this invention's system is to help the hospital determine wherethis should be done—i.e., the blood bank, central supply, or surgicaldepartment. This is determined by the skill of the staff 202, theavailability of staff 24 hours a day, and the ability to monitor andmaintain storage equipment and alarms. The invention promotes thedevelopment of a specific policy and procedure regarding how the tissuepieces will be accepted from tissue bank 14, and which specific staff202 will be responsible for logging in the tissue. The logging processincludes a unique identification number for each piece of tissue(specially assigned where necessary), coupled with the expiration dateand acceptable temperature range for each tissue product.

The tissue login procedure 200 conducted by the hospital staff 202 isassisted by the tissue receipt GUI 300 shown in FIG. 13. This screen ofthe software program 54 is accessed by means of clicking on the “receivea tissue order” icon 82 of the home page GUI 60 shown in FIG. 4. Theselection of this icon 82 will cause the software program to retrievethe tissue receive GUI 300 shown in FIG. 13, which lists a number ofopen purchase orders 302 of transplantable materials.

By selecting the particular purchase order 302 on GUI 300 to match thedelivered transplantable material, GUI 304 shown in FIG. 14 appearswithin the software program 54. The purchase order number 306, ordertype 307, supplier 308, order status 309, product description 310, andordered quantity 311 will automatically be populated by the system,using data inputted into tissue order GUIs 142 and 154 shown in FIGS.8-9.

The hospital staff member who received delivery of the transplantablematerial product should input his or her name into field 314, along withthe date and time 315. This information may be provided by means of adrop down box or other graphical input means. The medical establishmentfacility receiving the transplantable material should be entered into afield 316, and a specific storage location 317 assigned, including bymeans of drop down boxes.

After clicking onto the “next” icon 319, GUI 320 shown in FIG. 15 willappear. Again, the purchase order number source 322 and productdescription 323 data for the piece of transplantable materials will beautomatically populated. The user should enter information for thepackaging type 324 and inventory type 325 for the transplantablematerial. This includes whether the material is immediately availablefor use in a surgical procedure 326. If the transplantable material isreserved for a particular patient or surgery, radio button 327 should bechecked. Finally, the user should designate the specific type of storagefacility 328, temperature type (e.g., room temperature, refrigerator,freezer) 329, and temperature 330 under which the transplantablematerial should be stored.

Clicking the “next” button 332 calls forth GUI 338 shown in FIG. 16.This GUI prompts the user to record information unique to the particularpiece or pieces of transplantable material that have been received.Again, the purchase order (source, quantity ordered, quantity received,and product description fields 340, 341, 342, and 343, will beautomatically populated to confirm that the transplantable material wasreceived 220. The bar code assigned by the supplier on the packaging forthe transplantable material will be scanned by the user to convenientlyand accurately enter this information into field 344 and saved 345. Inaddition, the user must manually enter the information in field 346 forthe expiration date for the transplantable material, product lot number347, and field 348 for supplier-assigned unique identification numbers.

For products not assigned a unique identification number by thesupplier, the software program will also assign a unique tracking numberfor the transplantable material product so that it can be identifiedthroughout its custody by the hospital and ultimate implantation in apatient. A donor number 350 identifies the specific donor of thespecific piece of transplantable material.

Other important information pertaining to the piece of transplantablematerial that should be entered into the tissue receipt GUI 338 isquality control information. Check boxes 352, 353, 354, and 355 must bemarked by the user in order to prompt him to check whether thetemperature was adequately maintained for the transplantable materialduring shipment, whether the entire product label is legible, whetherthe packaging for the transplantable material is intact, and whetherother required quality checks for the product are satisfied. If the userdoes not check these boxes, the software does not allow him to proceed.In a preferred embodiment, failure to check a particular box may producea warning message with an opportunity for an authorized supervisor tooverride it if the problem (e.g., an illegible product label for knownproduct) is deemed to be acceptable. If, on the other hand, the productshould be rejected and returned to the supplier; then a check box 356 ismarked. If desired, a verifier can be used to double check thisinformation with the verifier identified in a field. Additional writtencomments regarding the inspection results can be entered.

The invention encourages the hospital to establish inspection criteria239 (FIG. 3) for the incoming transplantable material. This process stepincludes verification upon receipt of the transplantable materialproduct from the tissue bank 14 that package integrity of the tissue issatisfied to avoid infection or spoilage of the tissue. The staff member202 should also verify that the temperature range for the piece oftransplantable material during transport from tissue bank 14 wascontrolled and acceptable in accordance with FDA regulatory standards orthe manufacture's recommendations.

The invention also encourages the medical establishment to createspecific policies and procedures regarding how it should handle, store,and transplant the transplantable material 12. This determination 270(FIG. 3) begins with careful review and maintenance on file of thepackage inserts for each type of transplantable material used by theestablishment. Each supplier of tissue has created differentinstructions for how their products should be transported, handled,stored reconstituted, and used. These instructions are approved by theFDA. Great care should be taken to ensure that the package integrity ismaintained for the products during transportation and handling in orderto avoid introduction of contaminants into the product.

Clicking “submit” button 358 enables the received transplantablematerial product and its identifying data to be saved. A summarizingdata entry 360 appears in GUI 338. Field 362 allows the nexttransplantable material product to be received 220.

The transplantable materials must also be maintained at their propertemperatures during their storage at ambient temperature or inrefrigerators and freezers at the hospital. The FDA-approved packageinsert for each type of tissue product will specify the appropriatetemperature or temperature range. The hospital must determine what typesof refrigerator or freezer units it will use, along with the associatedmonitoring and alarm equipment. Appropriate policies and procedures 64(FIG. 3) need to be established to ensure continuous monitoring of thetemperature conditions in the refrigerator and freezer units with acentral alarm system or chart recorder. A number of transplantablematerial products that are stored at ambient temperature do not specifythe temperature range that needs to be maintained. The inventionencourages that the hospital create an appropriate temperature range. Ifnot specified, the invention suggests careful review of the packageinserts for the ambient temperature products used by the hospital. Therange is then created by taking the highest low temperature identifiedin the package inserts and the lowest high temperature designated inthese inserts.

Alarms for each storage unit should be set so that the alarm soundsbefore the temperature within the unit exceeds the predeterminedtemperature range. In this manner, the ambient storage area,refrigerator or freezer units will maintain a temperature condition thataccommodates the transplantable materials stored within.

Schedules for the periodic inspection and maintenance of therefrigerator and freezer storage units must be created. Periodic testingof the alarm systems operatively connected to the storage units and theemergency power source should also be scheduled. It is also important tomaintain daily records of the actual storage unit temperature conditionsto prove that the transplantable materials, in fact, were stored attheir required conditions. Each piece of transplantable material shouldbe identified within the log record by its unique identifier number,date, time and storage or handling location to document its exactcondition until final disposition, transplant or discard.

If the surgery unit 20 maintains its own storage units fortransplantable materials, then it must establish similar policies andprocedures for monitoring the temperature conditions therein, inspectingthe valid operating conditions thereof, and documenting the actualtemperature conditions of the refrigerator and freezer units. Thesurgical unit 20, however, must also maintain precise records for eachand every piece of transplantable material that it handles and uses insurgical procedures. Such records should identify the specific piece oftransplantable material, its condition and all reagents or othersupplies introduced to it prior to its transplantation or implantationinto the patient.

GUI 700 shown in FIG. 16 a enables the user to record periodicinspections of the temperature of a storage unit identified in field702. The inspection date and time 704, temperature 706, and any notes708 are entered into their respective fields. Clicking on “Save” button710 adds the new data entry to the last-ten record entries summarized infield 712. The staff member who measured the temperature of the storageunit is also identified in field 714.

Another important step carried out by staff within the surgical unit 20will be the reconstitution of the transplantable material from itsstorage condition to a condition necessary for its use in surgery. Thisis determined by the package insert and current good medical practice.This will typically include the immersion of the tissues, like bone,into a sterile saline bath with or without antibiotics. Other humancells, tissues, NBI, and organs are reconstituted with appropriatereagents. The nurse or other qualified/trained staff member designatedto conduct such reconstitution step must carefully read and adhere tothe specific instructions printed in the package insert for thetransplantable material product and make the implanting surgeon awarethat they are deviating from the FDA-approved package insert. Thesurgeon decides based on his medical judgment whether the change fromthe package insert is merited. At the end of the surgical procedure, thetissue usage identification cards (“TUIC”) must be completed for theproduct implanted into the patient and promptly returned to tissue bank14.

In some cases, a hospital 16 may actually serve as a supplier oftransplantable materials to other medical establishments. This often isthe case for “sister” hospitals or large hospitals that internallysource transplantable materials and use them in their other surgicalprocedures. The comprehensive tissue management system 10 requires thehospital 16 to periodically ask itself these questions:

-   -   Does it produce human cells, tissue and cellular and        tissue-based products (“HCT/Ps”), including stem cells,        reproductive cells, tissue or surgical bone?    -   Does it store purchased tissue and ship it to another        institution that is not part of its organization? For example,        does it supply a VA Medical Center or other hospital within the        community?    -   Does it store tissue from one patient case on the chance that        the surgeon needs it for another patient with the exception of        vessels used in organ transplant?    -   Does it perform additional processing on incoming tissue? For        example, gas sterilization of bone for further use.    -   Does its testing lab perform tissue donor testing for        communicable diseases?    -   Does its lab test specimens for organ donors, and are such        results used to determine eligibility for tissue donors?        If the answer to any of these questions during this source        facility regulatory compliance step 280 depicted in FIG. 3 is        “yes,” then the hospital 16 must register itself with the FDA        much like a tissue bank 14 does.

A critical component for the comprehensive tissue management method 26of the present invention is the hospital staff 202. As shown in FIG. 3,a trained staff member must be designated with responsibility for eachof the process steps described above. Every effort must be made toensure that the responsible staff member has the required educationalbackground 205 (FIG. 3) for conducting the process step. Also importantis ensuring that such staff members will actually be available at therelevant time to carry out the activity step. For example, iftransplantable material is maintained in a surgical unit and theresponsible person is unavailable to respond to an alarm sounding on arefrigerator unit, this undermines proper operation of the comprehensivetissue management system 26. All designated staff members should beprovided the necessary training 206 to discharge their responsibilities.They should also be provided the necessary policies and procedures 207by hospital management that allows them to perform their duties withoutrisk to themselves or the patient.

In order to ensure that the above-described process steps are carriedout, the comprehensive tissue management system 10 should be embodiedwith a record-keeping system that requires the completion of individualrecords 208 attesting to the completion of the individual process steps.The comprehensive tissue management system 10 is preferably embodiedwithin a computer tissue tracking and tracing software system.Individual screen shots for a process step could require completion ofthe necessary data entry before the computer can progress to the nextscreen shot.

Finally, a periodic internal audit 209 must be conducted by the hospital16 for all of the process steps that form the acquisition and storagecomponents 26 of the comprehensive tissue management system 10. Only inthis manner can the hospital management be assured that their staff iscomplying with the necessary policies and procedures, and takecorrective action where necessary.

FIG. 17 illustrates the tissue tracing portion 32 of the comprehensivetissue management system 10 in greater detail. The objective of thissystem is to provide an adequate record of the transplantable material'shistory in case of an adverse reaction 30 in patient 22 after surgeryor, if the tissue bank issues a recall and the patient who receives thetransplantable material needs to be identified. For example, if theadverse reaction is an infection and is due to the operativecontamination or the management of the bone graft in the hospital, thenthe problem is localized to the hospital and can be addressed byimproving the hospital's practices. If, on the other hand, the infectionis determined by investigation 30 to have been caused by the tissuegraft, then the tissue needs to be traced back to tissue bank 14, so thesupplier can be warned. A recall of similar transplantable materialsupplied by tissue bank 14 to the hospital 16 and other medicalestablishments may be necessary. Furthermore, there have been instancesin which the FDA has issued recalls of transplantable material as aresult of their investigations into poor practices of tissue banks, bothaccredited and non-accredited by the American Association of TissueBanks (“AATB”). In some cases, follow-up diagnostic and medicaltreatment of other patients who were implant recipients of the similartransplantable material may be warranted as well.

To monitor the history of the tissue during its life in the hospitalrequires documentation of multiple steps starting with its entrance inthe hospital and its maintenance in the storage locality 18 (FIG. 3).This will include assigning a unique identification code to the bonegraft products, confirming the package integrity and safe condition ofthe bone graft upon receipt from the tissue bank 14, recording theactual temperature conditions, and identifying all staff members whohandle the bone graft and the date and time of any such possession orhandling activities from the time of initial login until the bone graftis transported to the surgical unit 20 for use in a surgery. Many of theprocess steps described above for the acquisition and storage trackingportion 26 of the comprehensive tissue management system can be employedto support the documentation steps.

Once the transplantable material 12 reaches the hospital 16 and islogged in, it will be maintained in any of a number of possible storagelocations 18 in the hospital before it is transported to the surgicalunit 20 for clinical use in a patient 22. Possible storage locations atthe hospital include the blood bank, central storage department and thesurgical unit. Clicking tab 70 of the home GUI 60 of FIG. 4 causes thesoftware program to produce GUI 362 shown in FIG. 17 a. This GUI screenitemizes the type of facility 363 and number 364 of storage unitlocations for each facility 365 of the medical establishment. It alsodefines the title 366, type 367, and proper temperature condition 368for each such storage unit.

By selecting “Move Tissue” hyperlink 84 in the home GUI 60 of FIG. 4,the move tissue GUI 370 shown in FIG. 18 is called up by the softwareprogram. This GUI enables the user to choose a particular medicalestablishment facility 372, along with a specific piece oftransplantable material stored there. This transplantable material maybe identified by its bar code number 374 or unique ID number, assistedby selection of a look-up table 375. Alternatively, the user may selectthe radio button 376 for any of the storage locations within the medicalestablishment facility to produce an itemized list 378 of all of therecorded transplanted materials stored therein. Selection of aparticular transplantable material item will cause the software program54 to call up GUI 374 shown in FIG. 19.

The data fields for the product 375, bar code number 376, lot number377, donor/unique ID number 378, expiration date 379, and long-termstorage condition and temperature 380 will be automatically populatedwithin their respective fields in GUI 374. Also automatically populatedwithin GUI 374 will be the current storage location 382, date of lastmovement 383, and staff member responsible for the previous data entryfor the piece of transplantable material. An entry 386 summarizing thehistorical storage data for this transplantable material is alsoprovided.

By clicking “next” button 388, the software program produces GUI 390shown in FIG. 20 for purposes of documenting the transfer of an item oftransplantable material within a medical establishment. The product andits bar code and expiration date will be automatically described withinfields 392, 393, and 394, respectively, using data previously enteredinto prior GUI's. The date and time of the transfer of thetransplantable material must be recorded in field 395, along with theidentities of the staff member releasing the transplantable materialfrom the present storage location 396, and receiving it at the newlocation 397. A reason for the transfer should be entered into field398, which could include its use in a surgical procedure.

The new storage location should be recorded in field 400, along with thenecessary type of storage temperature (e.g., room temperature) 402 andactual storage temperature conditions 403. If the transplantablematerial is being transferred to a different facility, then this factshould be recorded in field 404. Moreover, if the item of transplantablematerial has been reserved for a particular surgery, then check box 406should be checked, and the surgery date, patient identification number,physician order number, and doctor recorded in fields 407, 408, 409, and410, respectively.

Finally, the system requires the user to inspect the transplantablematerial item once again, guided by the check boxes 412, 413, 414, and415 for adequate temperature maintenance during storage, product labellegibility, intact product packaging, and other required quality checkscriteria. Failure to make these inspections and check the correspondingboxes will prevent the user from exiting this GUI screen 390 afterclicking the submit button 417.

In this manner, an item of transplantable material will receive separateentries within tissue movement GUIs 374 and 390 for each time that it istransported to a new storage location. This could include return of thetissue item to the supplier in the event, e.g., that the tissue is nolonger needed, there is a recall by the supplier, or if the tissue wasdetermined by the hospital's quality control inspection to be defective.

In the vent of a supplier-generated recall, several steps must be takento insure that the tissue is removed from the hospital or surgicalfacility inventory and storage and prevent future use. Once the recallnotice is received by the hospital from the FDA and/or the manufacturer,the staff charged with processing the recall must enter the identifyinginformation (e.g., unique ID, serial number, lot number) from thetransplantable material or NBI into the system.

Once the identifying information from all of the transplantable materialor NBI included under the particular recall is entered into the system,the system requires the user to identify the specific type oftransplantable material involved in the recall. This feature safeguardsagainst duplicate identifying information from two distinctmanufacturers being confused and erroneously included or excluded fromthe recall process.

At this point, the system pinpoints if the hospital has or has had anyof the recalled product in its inventory. If so, the system identifiesthe product, so that a staff member may remove the product frominventory, using the “Move” standard operating procedure. Additionally,the “Recall” standard operating procedure isolates any recalled productthat has been already implanted into a patient. If so, the systemidentifies the patients and has the capability of generating letters tobe sent to the affected patients.

Finally, if the number of products being recalled by the manufacturer islarge, the user can place a prospective hold on that manufacturer. By doso, when products from this supplier are being received into theinventory in the future, the system alerts the user, and requires asupervisor to override before the particular product(s) can be acceptedinto inventory. The goal of this feature is to prevent recalled productfrom entering the hospital's “clean” inventory.

Another instance of moving transplantable material within a medicalestablishment facility could include discarding of the tissue after,e.g., its expiration date has passed, or quarantining of the tissueinside the hospital in the event of an adverse reaction investigationwhere safety of a similar piece of tissue is under review. In thismanner, the related tissue will not be used in a surgical procedureuntil it is cleared. When tissue is used by the hospital in a surgicalprocedure, this will be recorded in the “issued” field.

Thus, the historical record provided by the comprehensive tissuemanagement system 10 of the present invention enables the hospital'shandling of the tissue item to be traced in the event of an adversereaction investigation or product recall. This is an important featureof the release and utilization portion 32 of the comprehensive tissuemanagement system 10 of the present invention.

In the case of surgeries, an item of transplantable material needs to beselected. By clicking on the inventory tab 68 of the home GUI 60 of FIG.4, an inventory listing of the transplantable material stored within themedical establishment is provided. An example of such a listing is shownin GUI 420 of FIG. 21. Filter 422 may be applied to select thetransplantable material samples using different search criteria likesupplier 424, classification 425, tissue type 426, inventory type 427,temperature 428, and surgery type 429. GUI 420 shows thesetransplantable materials sorted by supplier 424.

The major portion of GUI 420 contains a table exhibiting variouscharacteristics for these transplantable materials. These characteristicdata columns include supplier 426, product description 427, purchaseorder number 428, bar code identification number 429, product expirationdate 430, inventory type 431, status 432, facility 433 where the productis stored, specific storage location 434, and temperature type 435. Notethat the unique identification number for the product sample could beused instead of the bar code number 429. These data fields areautomatically populated by data entered previously during the tissuereceipt, moving, and storage functionalities. The inventory type entry431 will indicate whether a specific transplantable material sample is ageneral stock item, or whether it is on consignment from the supplier,such as a tissue bank. Meanwhile, the status entry 432 indicates whetherthe product item is available for assignment to a surgery, or whether ithas already been reserved for a patient in another surgery.

The inventory list of GUI 420 also features color-coded entries forparticular transplantable material samples. For example, ared-highlighted entry might call attention to samples that are alreadyexpired. They need to be removed from inventory and discarded beforethey are accidentally implanted into a surgery patient. Ayellow-highlighted entry, on the other hand, might flag productspecimens that are still safe to use, but will expire soon. In thiscase, they should promptly be selected for a surgery, so that they willnot be wasted after they expire.

Once the transplantable material 12 reaches the surgical unit 20,thorough records need to be created concerning the clinical use of thisspecific bone graft. This includes identification of the staff memberwho accepts the bone graft, identification of all surgical staff membersinvolved in preparing the bone graft for its use in the surgicalprocedure, and recording the dates, times and personnel for all suchactivities.

Accessed by means of implant tissue hyperlink 86 of home GUI 60 of FIG.4, GUI 440 shown in FIG. 22 allows searches to be conducted for patients22 or surgeries 20. Under patient finder filter 442, the name 444, MRN445, and gender 446 of a specific patient may be entered, and the searchbutton 447 clicked. A patient search results list 449 is producedthereby. A list of surgeries 450 conducted at the facility is alsoproduced. These are surgeries that have already occurred.

As shown in GUI 454 illustrated in FIG. 23, selection of the SherryVowhall patient entry 452 produces a specific list 456 of surgeriesperformed on her at Methodist Hospital. A further list 458 oftransplantable material products implanted in Ms. Vowhall during thesesurgeries also appears in GUI 454. Selecting radio buttons 457 enablesthe specific records for the surgeries to be viewed.

New patient entries may be created by selecting hyperlink 460. A newadverse reaction investigation may be entered into the system byclicking on hyperlink 462. Meanwhile, selection of hyperlink 464 enablesthe user to create a new surgery record, resulting in calling up GUI 470shown in FIG. 24.

Within this GUI screen 470, basic information for the surgical procedureis entered. This includes the patient's identification number 472, anidentification number 473 assigned by the hospital to the surgicalprocedure, the start and end dates and times 474 and 475 for thesurgery, the surgical facility 476, the specific surgical location(e.g., a specific operating room within the medical establishment) 477,the procedure type 478, and surgical procedure 479. Drop down boxes withpre-entered hospital specific information can be provided to help theuser with the entry of the data. Other procedural details can berecorded in field 480. Clicking on the “next” button 481 produces GUI490 depicted in FIG. 25.

GUI 490 accommodates the recordation within the system of all staffmembers 202 of the medical establishment facility that handle, prepare,and implant the bone graft 12 into the patient. This includes thesurgeon 492, internal product quality inspector 493, person whoreconstitutes the bone graft 494, and person who dehydrates the product495. Staff members and their role that they play with respect to thebone graft may conveniently be added via drop down boxes 496 and 497.The information fields regarding the surgical procedure 498 areautomatically populated by data inserted elsewhere into the system.

“Next” button 499 produces GUI 500 shown in FIG. 26. The bar code number502 for the transplantable material is entered, and a lookup button 504that accesses the facility's inventory is provided by the system to linkthe product's identifying information with the patient's MRN.Preferably, the bar code number is scanned into the system from theproduct package. The unique product identification number assigned bythe medical establishment facility may be used as a substitute for thesupplier's bar code number.

Clicking “next” button 506 transports the user to GUI 510 depicted inFIG. 27. In this GUI, specific information can be recorded regarding thespecific use of the transplantable material. Descriptive fields 512concerning the product and its supplier and expiration date areautomatically populated by the system. The user should click thepertinent radio buttons 514 and boxes 516 to indicate whether the tissueproduct was implanted successfully within the patient, whether theproduct was used in its entirety or discarded, or whether the productwas opened but not used within the surgery, or whether the tissue wasexplanted. Likewise, any commingling of the tissue with other tissueproducts should be recorded. The user must also confirm whether thetissue product was reconstituted strictly in accordance with thesupplier's instructions 517, or whether any deviations from thisprocedure were made 518.

An important processing step by the surgical unit is the reconstitutionof the bone graft product prior to its implantation in patient 22. Aspreviously described, this should be done strictly in accordance withthe instructions on the package insert. Documentation should be producedto indicate what supplies like syringes, heparin, saline or basins wereactually used to reconstitute or prepare the bone graft, and confirmthat all such supplies were used prior to their indicated expirationdates. The reconstitution products (e.g., saline solution) are recordedin field 520. Any modifications to the tissue should be noted in field522, and surgical notes may be added in field 524.

At the end of the surgical procedure, the tissue usage information cardshould be completed and returned to tissue bank 14 to provide additionaldocumentation of the clinical use and disposition of bone graft 12 inpatient 22. The information contained within GUI 510 can be sent to thetissue bank to facilitate this reporting step. Specific policies andprocedures need to be established to determine who will complete thesecards according to the tissue bank requirement, since completion andreturn of such tissue usage information cards is frequently overlookedwithin the hospital industry.

GUI 530 shown in FIG. 28 produces a confirmation summary of the surgicalprocedure information, and automatically processes the tissue usageinformation cards, using previously entered data regarding thistransplantable material. Submitting the information via button 536allows it to be printed in batch format on a periodic basis for themedical establishment facility management and/or transplantable materialsupplier.

The essential element of the release and utilization portion 32 of thecomprehensive tissue management system 10 of the present invention isthorough and concurrent record keeping. Failure to document importantsteps in the acceptance, handling, storage, transportation, processingand clinical use of the tissue and associated reagents will greatlyundermine the integrity of the system and put the patient at risk.

The hospital 16 should establish the time period for retention of eachrecord within portion 32 of the comprehensive tissue management system10. In the case of login sheets and recorded procedures for thetransplantable material, such records should be maintained for at least10 years. Any records related to the transplantable material like tissueusage information cards, preparation materials, central alarm/chartrecorders must be kept 10 years after the date of distribution,transplant or expiration date of the material in question, whichever islatest.

A procedure for version control must also be established for allprocedures that affect the transplantable material, including a uniquename for each procedure, a version number and date when it becameeffective, and when the previous version no longer applies in order tokeep the documentary records and procedure requirements clear.

As described previously for the portion 26 of the comprehensive tissuemanagement system 10, designated hospital staff members 202 that arepart of the release and utilization portion 32 of the system need to beassigned responsibility for keeping and maintaining all records andother documents associated with the comprehensive tissue managementsystem. While a requisite degree of education 205 may be helpful,character traits of conscientiousness and thoroughness, as well asavailable time may be more helpful for any such staff member. Alldesignated staff members should also be provided adequate training 206in such tasks as how to read temperature charts, inspect refrigerationor freezer storage units, confirm the instructions on transplantablematerial product insert sheets, etc. These hospital staff members 202should also be provided understandable policies and procedures 207 tohelp them do their part to support the integrity and accuracy of thecomprehensive tissue management system 10. Periodic internal andexternal audits 209 should be scheduled by hospital management toconfirm that all of the necessary steps pursuant to the comprehensivetissue management system are accomplished.

The comprehensive tissue management system 10 is predicated upon theproposition that hospital management and staff will actively investigateadverse reaction 30 and take corrective action in response to anyadverse reaction in a patient 22. To accomplish thorough investigationsof adverse reactions the invention has created the concept of “MedicalCladistics.” Cladistics is the branch of biology that determinesevolutionary and taxonomic relationships between organisms based onderived similarities. Similarly, medical cladistics looks for derivedsimilarities in investigation of clinical problems such as adversereactions so appropriate risk categories can be created. For example, ifa patient develops an infection following surgery in which tissue hasbeen used, and an investigation shows that other patients were operatedon in the same operating room (“OR”) suite developed similar infections,the “risk clade” is the OR suite, not the transplantable material, orthe OR staff and the equipment sterilizer.

If a transplantable material product was associated with an infection,then the risk clade would have to be identified. Some transplantablematerial products can be more harshly treated than others. For example,tendons do not receive the same sterilizing treatments used by sometissue processors for bone. If an infection due to the transplantablematerial were bacterial and the transplantable material productimplicated was a tendon, than the risk clade would be the other tendonsfrom the same donor, not necessarily the bone products. If the infectionwere hepatitis, than all products from the donor may be the risk clade.

Investigation of the risk clade involves both the hospital where thetransplantable material was transplanted and the transplantable materialprocessor. Therefore, the transplantable material supplier must benotified immediately and a full investigation of the donor andprocessing quality control methods would be necessary to resolve thecase.

The process of identifying a risk clade begins by defining an adversereaction. This requires thorough evaluation of the actual orthopedic orother clinical and surgical practices employed by the hospital and itsphysicians. Factors that may influence adverse reactions include:

-   -   Physician preference for certain proprietary transplant material        products and supplies. Some products carry greater risks than        others.    -   How such products are normally prepared within the hospital.    -   Pre and post-operative antibiotics that are commonly used by the        surgical team.    -   Are tissue products soaked in antibiotics prior to their        implantation?    -   Incidence of infections in the hospital comparing allograft        versus metallic devices.    -   Does the surgeon perform a gram stain or culture of the tissue        product prior to its implantation?    -   Determining whether adverse reaction in a patient is based upon        cultures, symptoms, or both.

The hospital 16 must establish policies and procedures to reinforce theprompt investigation and reporting of adverse reactions to answer thefollowing questions:

-   -   Who within the hospital's management is responsible for        receiving information concerning adverse events revealed during        the post-operative assessment 28 (see FIG. 1)?    -   How are these events to be documented?(e.g. evaluation, report,        log, etc.).    -   Who is responsible for determining if the adverse event was        secondary to the tissue implant?    -   Who notifies the tissue bank and receives their evaluation and        report?    -   Who is responsible for requesting additional information and        testing, and for completing the investigation?    -   What other transplant materials received from the tissue bank 14        need to be traced and quarantined within the hospital 16?    -   All adverse event records need to be periodically reviewed for        completeness.    -   Who will report the investigation conclusions to the clinician?

In the event that the tissue bank reports that the transplantablematerial was the cause of the adverse reaction, or is otherwisecontaminated, then the hospital must have in place established policiesand procedures for quarantining all impacted transplantable materialsstored within the hospital's inventory. Such procedures encompass theability to trace such transplantable materials, notification of thepatient's physician if the transplantable material was alreadytransplanted, maintenance of a report or log that accounts for all suchtransplantable material products, and an identification of a departmentand specific staff members responsible for doing so.

Patients who have received a transplant from donors who subsequently arefound to have HIV, HTLV-I/II, viral hepatitis, or other infectiousagents known to be transmittable by tissue must also be identified andinformed of infectious risks. This includes donors who have donated morethan one time, such as donors of reproductive tissue, stem cells, andsurgical bones. When such a donor is found to have a confirmed positivetest for infectious agents, then all previous donations oftransplantable materials need to be identified via the release andutilization portion 32 of the comprehensive tissue management system 10,and a determination of which donations could have occurred while thedonor was within the window period for this infectious agent must bemade. The hospital's procedures in cooperation with the supplier shouldinclude:

-   -   Who is responsible for identifying all previous donations?    -   Who is responsible for determining which previous donations are        at risk?    -   How should all subsequent recipients of the infected transplant        material from this donor be identified?    -   How should all such recipients be notified?    -   Who is responsible for counseling the recipients of the infected        transplant material?    -   Is there a policy for follow-up testing of the recipients?    -   Is notification of the state health department or other        regulatory agencies required?    -   Is there a procedure and log to document all of this        information?    -   Is the individual who counsels the recipients properly educated        and trained?

The adverse reaction investigation GUIs of the comprehensive tissuemanagement system 10 are depicted in FIGS. 29-34. GUI 540 shown in FIG.29 is accessed by means of selecting tab 72 or “record adverse reaction”hyperlink 88 of home GUI 60 shown in FIG. 4. Within this screen, patientidentification number 542, the date on which an adverse reactionreported by the patient occurred 544, and the current disposition of themedical establishment's investigation of the reported adverse reaction546 may be inserted. General notes regarding the investigation may berecorded in field 548.

Clicking “next” button 549 transports the user to GUI 550 illustrated byFIG. 30. The patient and incident information from GUI 540 will beautomatically populated in field 552. The specific surgery performedupon the patient 554 is identified by means of a drop down box. Thetissue products previously recorded in GUI 500 for that surgicalprocedure are added by means of field 556 and “add tissue” button 557 tosummary field 558.

The next screen accessed by means of “next” button 559 is GUI 560 shownin FIG. 31. Using drop down box 564 and notes field 566, the user canrecord his initial opinion concerning the cause of the patient's adversereaction. This is summarized in field 568.

GUI 570 depicted in FIG. 32 is accessed via “next” button 569. Usingdrop down box 572 and notes field 574, the user can record the symptomsexperienced by the patient due to the adverse reaction. These symptomsare cumulatively summarized in field 576.

GUI 580 shown in FIG. 33 allows the disposition of the adverse reactioninvestigation 582 to be recorded, along with additional general notes584 concerning the investigation. A check box 586 also instructs thesoftware to re-process the tissue usage information card produced by GUI510 of the system, and resend this information to the appropriatesupplier to inform them of the adverse reaction. By clicking on button588, the reported information in this adverse reaction module can besubmitted to the facility's management and regulatory authorities.

The end result of this submission is GUI 590 shown in FIG. 34. All ofthe critical information for a selected patient suffering an adversereaction is automatically populated by the system in field 592,including name, date of birth, age, gender, MRN, last medical procedure,number of transplantable material items implanted, and the dispositionof the investigation. The diagnostic tests run on the patient, andresults thereof are automatically populated within field 594. Finally,an identification of the various notifications and reports owed to theFDA, patient, and supplier and the status thereof are clearly identifiedin field 596. In this manner, the comprehensive tissue management system10 of the present invention creates an accurate record of the adversereaction investigation 30 that prompts appropriate follow-up by thehospital's staff member 202 with regard to the patient 22, tissue bank14, and regulatory authorities.

Another important feature of the tracing portion 32 of the comprehensivetissue management system 10 of the present invention is its facilitationof supplier recalls of transplantable materials. Initiated by thesupplier or FDA, the medical establishment must ascertain whether therecalled product in question exists in its storage facilities awaitingsurgical implant into a patient, or whether it has already beenimplanted into a patient.

GUI 600 shown in FIG. 35 may be readily accessed by means of tab 74 or“process supplier recall” hyperlink 90 of home GUI screen 60 of FIG. 4.By selecting the supplier from drop down box 602, a listing of all ofthe recalls by or for that supplier is produced in field 604, along witha brief description of the recall 606 and its date 608. “New recall”hyperlink 603 enables the user to institute a new recall recordation forthat supplier, adding an entry to field 604. This information is helpfulfor the staff of the medical establishment.

The relevant information for a supplier recall is entered into GUI 610illustrated by FIG. 36. Such data includes the supplier 612, recallnumber 613, date of the recall 614, starting and ending dates 615 and616, respectively, during which the transplantable material was known tobe processed, and the reason 617 provided by the supplier or FDA for therecall. Notes may also be added to field 618.

Clicking “next” button 619 takes the user to GUI 620 shown in FIG. 37.Descriptive data concerning the supplier, recall date, and reason forthe recall are automatically populated in field 622. The user can thenuse radio buttons 624 to indicate whether bar code numbers, uniqueidentification numbers, lot numbers, serial numbers, donor numbers, orproduct codes will be used to identify the transplantable materialproducts. In this case, “bar code numbers” is checked 625. The bar codenumbers can be typed or scanned into field 626, with the “add” button627 clicked to add each bar code number to summary field 628.

“Next” button 629 is then clicked to transfer the user to GUI screen 630depicted in FIG. 38. The user enters the tissue classification andtissue type into fields 634 and 635, respectively, via drop down boxes.The information is summarized in field 636. This information provides anextra filter for the internal search conducted by the system for therecalled tissue product. This is important for avoiding duplicateproduct numbers, which could otherwise cause erroneous contacts ofhealthy patients who did not receive the recalled product.

GUI 640 shown in FIG. 39 provides a summary screen of the recallinformation and transplantable material search results. Based upon theone bar code number 642 and tissue type 643 entered into GUIs 620 and630, a single patient 644 was found to have received the recalled tissueproduct.

Clicking box 645 will cause the system to produce a list identifying allof the tissue items that need to be immediately removed from the medicalestablishment's storage inventory. Clicking box 646 produces a list ofall patients into whom recalled tissue products were transplanted, whoneed to be notified of the tissue product recall, because they could bepotentially adversely impacted. Finally, clicking box 647 sets up awarning flag within the system to notify the medical establishmentfacility in case any of the recalled tissue product should beaccidentally delivered to the facility in the future by the recallsupplier. The system will require an authorized supervisor to approveany check-in receipt of the material into the storage inventory in caseit is safe to use it.

In its simplest embodiment, the comprehensive tissue management system10 of the present invention may be a paper record keeping system. Thismay be particularly appropriate for relatively small medicalestablishments that do not handle and process enough transplantablematerials to justify the cost of a computer-based system. Therequirements established by the medical establishment for filling outand completing such paper forms and submitting them to appropriatemanagers may be sufficient for ensuring that the various processingsteps for handling, storage, reconstitution, and surgical use of thetransplantable material by staff members are being conducted in a mannercompliant with prevailing regulations and industry standards, and that athorough document record is produced therefore. However, it is importantto incorporate within such policies and procedures safeguards forensuring that all of these internal requirements are met by staffmembers in a compliant and timely manner. This could include arequirement that records be filled out from one processing step beforethe next processing step for the transplantable material can beconducted by the same or another staff member. Periodic internal andexternal audits will also be important for assuring compliance.

However, the computer software system disclosed within this applicationfor the comprehensive tissue management system 10 provides the mostreliable method for providing a comprehensive information systemconcerning clinical usages of transplantable materials, and promptinghospital staff members to appropriately handle, store, process,transport, reconstitute, and use the transplantable material. Moreover,such a computer software-based system enables a user easily and quicklyto search for desired information. Furthermore, such a computer systemcan readily compile the information to produce reports that can be usedto manage and regulate clinical use of the transplantable materials, asillustrated by GUI 650 shown in FIG. 40. A variety of highly usefulreports 652 can be produced by the system using the template library.

The computer system can also notify those monitoring the tissue of anyof the steps described above by visual and/or audible means. Continualelectronic monitoring of the transplantable material allows the computersystem to store and display the entire history of a particulartransplantable material sample. The continual monitoring reduces therisks that the transplantable material sample's integrity has beencompromised.

Adequate policies and procedures adopted by the medical establishmentcan help with assuring that staff members are using the computer-basedsystem in a compliant and timely manner. Periodic internal and externalaudits will also be helpful.

The above specifications and drawings provide a complete description ofthe structure and operation of the comprehensive tissue managementsystem for acquisition and storage 26 of transplantable material andrelease and utilization 32 of transplantable material under the presentinvention. However, the invention is capable of use in various othercombinations, modifications, embodiments, and environments withoutdeparting from the spirit and scope of the invention. Therefore, thedescription is not intended to limit the invention to the particularform disclosed, and the invention resides in the claim and hereinafterappended.

We claim:
 1. A method for tracking the internal processing by a medicalestablishment of a piece of transplantable material provided by asupplier for subsequent transplantation or implantation into a patient,wherein a computer database, processor, and software program containingan organized set of instructions in coded language are provided forstoring and processing information, such method comprising the steps of:(a) assigning a unique identification code to the transplantablematerial upon its receipt by the medical establishment from thesupplier; (b) inspecting the transplantable material upon its receiptfrom the supplier for an unsafe condition; (c) providing a comprehensiveset of standard operating procedures adopted by the medicalestablishment covering at least one step for the login, handling,storage conditions, reconstitution, or surgical use of thetransplantable material by staff members of the medical establishment ina manner compliant with prevailing safety regulations and industrymandates; (d) entering into the database required data concerning howthe at least one step for the login, handling, storage conditions,reconstitution or surgical use of the transplantable material by thestaff member was carried out; (e) processing such entered data by thesoftware program which is built upon the standard operating proceduresto ensure that the step for the login, handling, storage conditions,reconstitution, or surgical use of the transplantable material wasconducted strictly in a manner compliant with the standard operatingprocedures before the next step for the login, handling, storageconditions, reconstitution, or surgical use of the transplantablematerial can be undertaken by the staff members; (f) assessing thepatient after transplantation or implantation of the transplantablematerial for evidence of an adverse effect; (g) investigating any suchadverse effect discovered in the patient to determine whether itconstitutes an adverse reaction; (h) reporting any such adverse reactionto the supplier that supplied the transplant material to the medicalestablishment; (i) wherein the transplantable material is chosen fromthe group consisting of human cells, tissue, or organs intended forimplantation, transplantation, infusion, or transfer to a patient,including, but not limited to: musculoskeletal tissues like bone,tendons, fascia, ligaments, cartilage, and bioengineered bone products;skin; cardiovascular tissues like heart valves, arteries, veins, andpericardium; reproductive cells like sperm, semen, oocytes, fertilizedeggs, and embryos; cellular therapies like stem cells, progenitor cells,cord blood, chondrocytes, bone marrow, and neural cells; dura mater;breast milk; eyes; corneas; organs; islet cells; parathyroids;autologous tissue; and synthetic and xenographic tissue used asreplacements for human tissue; as well as non-biologic implants,including but not limited to: titanium screws, titanium or carbon-fibercages or resorbable cages, fixation systems, saline or silicone breastimplants, synthetic polymers, prosthetic hips, knees and other jointcombinations thereof; as well as surgical instruments, equipment,reagents, and supplies associated with the transplanting or implantingof any transplant material into a patient; and; (j) wherein the medicalestablishment is an organization directed to the storage, research,transplantation, or implantation of transplantable materials chosen fromthe group consisting of hospitals, medical clinics, surgical centers,fertility clinics, tissue banks, organ donor banks, university andresearch facilities, diagnostic laboratories, and willed body programs.2. The transplantable material tracking method of claim 1 furthercomprising designating one or more staff members of the medicalestablishment with specific responsibility for conducting each of thesteps (a-f).
 3. The transplantable material tracking method of claim 1further comprising the step of certifying that the supplier currentlypossesses all required regulatory certifications and licenses to supplythe transplantable material.
 4. The transplantable material trackingmethod of claim 1 further comprising evaluating the safety or healthrisks posed by transplantable materials supplied by the supplier againstthe benefits provided by such transplantable materials.
 5. Thetransplantable material tracking method of claim 4, wherein input from atransplant surgeon is obtained when conducting the risk-benefitanalysis.
 6. The transplantable material tracking method of claim 1further comprising ensuring that a staff member of the medicalestablishment who performs any of the steps (a-f) possesses a relevanteducational background for performing such step.
 7. The transplantablematerial tracking method of claim 1 further comprising providingrelevant training to a staff member of the medical establishment whoperforms any of the steps (a-h).
 8. The transplantable material trackingmethod of claim 1 further comprising providing relevant policies orprocedures to the staff members in support of the reliable conduct ofany of the steps (a-h).
 9. The transplantable material tracking methodof claim 1 further comprising periodic auditing of the medicalestablishment to ensure that each step (a-h) is being conductedproperly.
 10. A method for tracing a piece of transplantable materialreceived by a medical establishment from a supplier throughout theinternal life of the transplantable material within the medicalestablishment until it is transplanted or implanted into a patient,wherein a computer database, processor, and software program containingan organized set of instructions in coded language are provided forstoring and processing information, such method comprising: (a)assigning a unique identification code for the transplantable materialupon its receipt by the medical establishment from the supplier; (b)providing a comprehensive set of standard operating procedures adoptedby the medical establishment covering the data that must be recorded toadequately describe at least one step for the login, handling, storageconditions, reconstitution, or surgical use of the transplantablematerial carried out by staff members of the medical establishment withrespect to the transplantable material; (c) documenting into thedatabase by a staff member data for the completion of at least one stepfor the login, handling, storage conditions, reconstitution, or surgicaluse applied by staff members to the transplantable material; (d)documenting in the database the identity of each staff member who comesinto contact with the transplantable material; (e) documenting in thedatabase the date and time of each processing step applied to thetransplantable material; (f) documenting in the database all materialsused to prepare and process the transplantable material; (g) documentingin the database the unique identification code of the transplantablematerial transplanted or implanted into the patient; (h) processing suchentered data by the software program which is built upon the standardoperating procedures to make sure that at least one of the documentationsteps (c-g) complies with the documentation requirements under thestandard operating procedures before the next step for the login,handling, storage conditions, reconstitution, or surgical use of thetransplantable material can be undertaken by the staff members; (i)tracing the transplantable material back to the supplier that suppliedit to the medical establishment or to the specific processing stepapplied by a staff member of the medical establishment to thetransplantable upon request; (j) wherein the transplantable material ischosen from the group consisting of human cells, tissue, or organsintended for implantation, transplantation, infusion, or transfer to apatient, including, but not limited to: musculoskeletal tissues likebone, tendons, fascia, ligaments, cartilage, and bioengineered boneproducts; skin; cardiovascular tissues like heart valves, arteries,veins, and pericardium; reproductive cells like sperm, semen, oocytes,fertilized eggs, and embryos; cellular therapies like stem cells,progenitor cells, cord blood, chondrocytes, bone marrow, and neuralcells; dura mater; breast milk; eyes; corneas; organs; islet cells;parathyroids; autologous tissue; and synthetic and xenographic tissueused as replacements for human tissue; as well as non-biologic implants,including but not limited to: titanium screws, titanium or carbon-fibercages or resorbable cages, fixation systems, saline or silicone breastimplants, synthetic polymers, prosthetic hips, knees and other jointcombinations thereof; as well as surgical instruments, equipment,reagents, and supplies associated with the transplanting or implantingof any transplant material into a patient; and (k) wherein the medicalestablishment is an organization directed to the storage, research,transplantation, or implantation of transplantable materials chosen fromthe group consisting of hospitals, medical clinics, surgical centers,fertility clinics, tissue banks, organ donor banks, university andresearch facilities, diagnostic laboratories, and willed body programs.11. The transplantable material tracing method of claim 10 furthercomprising designating one or more staff members of the medicalestablishment with specific responsibility for conducting each of thesteps (a-g or i).
 12. The transplantable material tracing method ofclaim 10 further comprising sending to the supplier a tissue utilizationinformation card for the transplantable material transplanted orimplanted in the patient.
 13. The transplantable material tracing methodof claim 10, wherein the tracing step is conducted in response to anadverse reaction detected in the patient into whom the transplantablematerial was transplanted or implanted.
 14. The transplantable materialtracing method of claim 13, wherein the supplier that supplied thetransplantable material to the medical establishment is notified of theadverse reaction in the patient.
 15. The transplantable material tracingmethod of claim 10, wherein the tracing step is conducted in response toa warning received from the supplier that supplied the transplantablematerial to the medical establishment.
 16. The transplantable materialtracing method of claim 13, wherein the adverse reaction investigationis conducted utilizing medical cladistics to identify risk clades. 17.The transplantable material tracing method of claim 10 furthercomprising ensuring that a staff member of the medical establishment whoperforms any of the steps (a-g or i) possesses a relevant educationalbackground for performing such step.
 18. The transplantable materialtracing method of claim 10 further comprising providing relevanttraining to a staff member of the medical establishment who performs anyof the steps (a-g or i).
 19. The transplantable material tracing methodof claim 10 further comprising providing relevant policies or proceduresin support of the reliable conduct of any of the steps (a-g or i). 20.The transplantable material tracing method of claim 10 furthercomprising periodic auditing of the medical establishment to ensure thateach step (a-g or i) is being conducted properly.
 21. The transplantablematerial tracking method of claim 1 further comprising sending a tissueutilization card to the supplier documenting the transplantation orimplantation of the transplantable material into the patient after thesurgery.
 22. The transplantable material tracing method of claim 10further comprising sending a tissue utilization card to the supplierdocumenting the transplantation or implantation of the transplantablematerial into the patient after the surgery.